Lankford Subcommittee Investigates FDA Drug Approval Challenges

Press Release

Representative James Lankford (R-OK), Chairman for the Oversight Committee's Subcommittee on Energy Policy, Health Care and Entitlements, held a hearing today on the Food & Drug Administration's (FDA)'s drug development and manufacturing challenges.

"The primary focus of the subcommittee hearing today was to help patients, who may be terminally ill, access potentially life-saving medications that await action in the FDA's arduous approval process," said Lankford.

"While the FDA meticulously evaluates drugs for safety and effectiveness in its regular approval process before releasing them for use, patients lose valuable time treating their terminal diseases with new, possible cures currently in the development phase. The ability for patients to gain access to these drugs, if they choose, prior to full approval by the FDA could renew a family's hope that their mom, dad, sister, brother or grandparent could get more time."

The Food and Drug Safety and Innovation Act of 2012 (FDASIA) provided the FDA a new opportunity to expedite and develop potentially life-saving medication, known as the "breakthrough therapy" designation.

After the passage of FDASIA, the President's Council of Advisors on Science and Technology (PCAST) issued a report entitled "Propelling Innovation in Drug Discovery, Development, and Evaluation." The report stated the FDA should go further to broaden the "accelerated approval" program to include more drugs.

"The medication development process can take months or even years. Our subcommittee wants to work with the FDA to do everything possible to streamline the approval process to make new, innovative drug treatments available quickly and safely. We will continue to work to provide patients opportunities to access the quality care they want and deserve," concluded Lankford.

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